SOURCE: DOR BioPharma, Inc.

November 15, 2007 08:00 ET

DOR BioPharma Announces CRADA With the Walter Reed Army Institute for Ricin Toxin Vaccine Research

EWING, NJ--(Marketwire - November 15, 2007) - DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR) to provide additional means to characterize the immunogenic protein subunit component of RiVax™, the company's preventive vaccine against ricin toxin. The CRADA will be carried out at the Division of Biochemistry at WRAIR and will encompass basic studies to reveal the underlying protein structure that is important in inducing human immune responses to ricin toxin. Ricin toxin is an easy to manufacture toxin that poses a serious threat as a bioweapon, primarily by inhalation.

Some of the features that are critical to induce protective immune responses by vaccination with RiVax™ include structural determinants in the core and the surface of the protein. The purpose of the CRADA is to obtain data to correlate protein structure with induction of protective immunity and long-term stability of the protein. These studies will involve comparison to structures of similar natural and recombinant proteins. RiVax™ induces antibodies that appear primarily in the blood of animals and humans. Some of these antibodies recognize determinants on the protein that are dependent on the conformation of the protein and may be involved in biological activity. Overall, antibodies in the blood are correlated to protection against exposure when the toxin reaches the circulation or when it comes into contact with lung surfaces, where the major effects lead to severe inflammation, tissue necrosis and death. RiVax™ induces such antibodies in humans as well as other animal species.

Lieutenant Colonel Charles B. Millard, PhD, Director of the Division of Biochemistry at WRAIR, will lead the studies to be conducted at WRAIR, which will include X-ray crystal analysis to determine the structural parameters of the RiVax™ vaccine. Dr. Millard and his team have conducted research on the structural biology of several protein toxins. "Immunization is the oldest and most effective method known to protect laboratory animals from ricin exposure because antibodies circulating at the time of exposure will inactivate the toxin," said Dr. Millard. "By visualizing and manipulating the precise structure of the ricin immunogen, it has become possible to develop safer and more stable human vaccine candidates."

"We have already shown that an injected form of RiVax™ is sufficient to induce circulating antibodies in the serum of animals that are correlated to protection of mucosal tissues in the lung and gastrointestinal tract," said Robert N. Brey, PhD, Chief Scientific Officer of DOR BioPharma. "A Phase 1 clinical trial has also shown that the same types of antibodies are induced in the serum of human volunteers vaccinated with RiVax™. As we move forward with additional clinical trials of RiVax™, it will be important to distinguish those features which are crucial for optimal human immune responses. We are currently evaluating RiVax™ in non-human primate studies to investigate protection against aerosol exposure, and are examining the correlates of human antibody responses. These responses depend strongly on the structural integrity of the protein."

The Company has been developing RiVax™ in a consortium effort between academic and industrial partners under several separate NIAID (National Institute of Allergy and Infectious Diseases) and FDA grants to DOR and University of Texas Southwestern (UT Southwestern) totaling approximately $15 million. In addition to UT Southwestern, development partners include Stanford Research Institute, the University of Kansas, Lonza Baltimore, and the Wadsworth Center of the New York State Department of Health in Albany.

Additionally, the RiVax™ development program has been recently awarded a $1 million FDA Orphan Products grant to carry out additional clinical testing of RiVax™ through UT Southwestern, planned for the first half of 2008. Dr. Ellen Vitetta of UT Southwestern has separately been awarded a grant for $2.2 million over five years to conduct research in fundamental areas to develop novel vaccine formulations and characterize immune responses in small animals. The outcome of that novel research will help support ongoing development of RiVax™.

About Ricin Toxin

Ricin toxin is a potent plant toxin that can be easily produced from abundantly available castor beans. Ricin toxin is highly toxic to humans and other mammals and is thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir as a by-product of castor oil production. It is second only to botulinum toxin as the most lethal natural toxin. Exposure to small amounts can lead to lung damage if inhaled with rapid onset of nausea, fever, and abdominal pain if ingested. General organ failure leading to death can occur within several days. The need for protective countermeasures against ricin toxin has been emphasized by its recent and continued use as a biological weapon. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.

About RiVax™

DOR BioPharma, Inc. believes it is the world leader in ricin toxin vaccine research. RiVax™ is DOR's proprietary vaccine developed to protect against exposure to ricin toxin and the first ricin toxin vaccine ever to be clinically tested in humans. There are currently no vaccines available to prevent ricin poisoning or medical treatments to care for poisoning victims. DOR has announced positive Phase 1 clinical trial results for RiVax™ which demonstrated that the vaccine is well tolerated and induces antibodies in humans that neutralize the ricin toxin. The functional activity of the antibodies was confirmed by animal challenge studies in mice that survived exposure to ricin toxin after being injected with serum samples from the volunteers. The outcome of the study was recently published in the Proceedings of the National Academy of Sciences. The Phase 1 clinical trial was conducted by Dr. Ellen Vitetta at the UT Southwestern Medical Center at Dallas, DOR's academic partner on the RiVax™ program.

About Walter Reed Army Institute of Research (WRAIR)

WRAIR is the single largest biomedical research facility of the United States Department of Defense (DoD) and has as its primary mission the conduct of biomedical research that is responsive to DoD and US Army requirements and the delivery of life-saving products including knowledge, technology, and medical material that sustain the combat effectiveness of the warfighter. WRAIR is known for advances in the field of tropical and infectious disease medicine and core programs in the basis for those diseases. WRAIR uses advanced technologies to produce solutions to medical concerns of military relevance. Core capabilities include antigen discovery and vaccine development for military relevant pathogens, drug discovery to address military needs, pilot production of quality biologicals that conform to current Good Manufacturing Practices (cGMPs), and testing of candidate vaccines, drugs and devices in endemic areas to counter infectious diseases.

About DOR BioPharma, Inc.

DOR BioPharma, Inc. (DOR) is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR filed a New Drug Application for orBec® with the FDA for the treatment of acute gastrointestinal graft-versus-host disease (GVHD) and has recently received a not approvable letter. A Marketing Authorization Application with the European Medicines Evaluation Agency has also been validated and is under review. orBec® is currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has recently initiated a development program with its Lipid Polymer Micelle (LPM™) oral drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis, as well as a development program with its oral azathioprine technology for the treatment of oral GVHD.

Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. DOR's ricin toxin vaccine, RiVax™, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.

For further information regarding DOR BioPharma, please visit the Company's website located at

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec®. Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: the FDA's requirement that DOR conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; DOR is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason.